- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02648737
Cognitive Behavioural Therapy for Anxiety Disorders in PD
February 17, 2020 updated by: Anja Moonen, Maastricht University Medical Center
Cognitive Behavioural Therapy for Anxiety Disorders in Patients With Parkinson's Disease: a Randomized, Controlled Trial of the Clinical Effectiveness and Changes in Cerebral Connectivity
Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a negative effect on gait, dyskinesia, freezing, on/off fluctuations, and quality of life.
With this Randomized Controlled Trial the investigators intend to 1) develop a Cognitive Behavioural Therapy (CBT) module for anxiety in PD 2) assess the effectiveness of this module in reducing anxiety symptoms, and 3) study the effects of CBT on cerebral connectivity.
Effective CBT treatment of anxiety will provide patients with behavioural and anxiety management techniques that can give lasting benefits, not only on anxiety symptoms, but potentially also on motor symptoms.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Anxiety is common in patients with Parkinson's disease (PD) and has a negative effect on several motor symptoms and quality of life in general.
So far, there is no treatment, neither pharmacological nor psychotherapeutic, that intends to specifically reduce anxiety symptoms in PD.
Cognitive Behavioural Therapy (CBT) is an effective treatment for anxiety disorders in patients without PD.
In PD, CBT is an effective treatment for depression and for impulse control disorders (ICD).
PD patients who received CBT for depression reported not only a reduction in depression and comorbid anxiety, but also a beneficial influence on coping and quality of life, compared to PD patients who only received clinical monitoring.
In addition to the clinical effectiveness, several studies have demonstrated the therapeutic effects of CBT on functional neural activity.
The two most common anxiety disorders in patients with Parkinson's Disease (PD): generalized anxiety disorder (GAD) and social anxiety disorder (SAD) are both characterized by dysfunctional connectivity between limbic areas (among which the amygdala) and the frontal cortex.
Recent functional imaging studies have shown that CBT can alter neural correlates of affective processing by increasing functional connectivity between limbic and frontal cortices.
The present study aims to study the clinical effectiveness of a CBT module for the treatment of the two most common anxiety disorders in patients with Parkinson's Disease (PD): generalized anxiety disorder (GAD) and social anxiety disorder (SAD) in a randomized controlled trial (RCT).
The CBT module will be based on existing modules for anxiety disorders in non-PD patients, and on modules for depression and ICD in PD patients.
In addition, the investigators aim to get more insight into biological dysfunction associated with anxiety in PD, as well as alterations in brain structure, brain function and cerebral connectivity due to CBT.
The investigators will study the biological correlates of successful treatment by using structural and functional magnetic resonance-imaging (MRI) scanning.
The present study further aims to study the long term clinical effectiveness of the CBT module, measured by the change anxiety score after 3 and 6 months follow-up.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lille Cedex, France, 59037
- Neurology and Movement Disorders Unit, Lille University Hospital
-
-
-
-
-
Maastricht, Netherlands, 6202 AZ
- Maastricht University Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Idiopathic PD according to the Queens Square Brain Bank diagnostic criteria
- Presence of clinically relevant anxiety symptoms, as operationalized by the Mini International Neuropsychiatric Inventory (MINI), sections for social phobia (F) and GAD (H), and/or a Parkinson Anxiety Scale (PAS) persistent score >9 and/or PAS avoidance score >3.
- Using a stable dose of levodopa or other antiparkinsonian medication for at least one month
- No other current psychological treatment for anxiety; pharmacotherapy (e.g., selective serotonin re-uptake inhibitors) is allowed if a stable dose is used at least 2 months prior to participation and the patient still meets inclusion criteria. During the trial the dosage should not be changed. Medication use and mental health care will be tracked throughout the study.
- Signed informed consent
Note: In order to achieve a representative study sample, patients will be included irrespective of their disease stage or their current antiparkinsonian medication.
Exclusion Criteria:
- Parkinsonian syndromes or neurodegenerative disorders other than PD
- Dementia or severe cognitive decline, operationalized as a Montreal Cognitive Assessment (MOCA) score < 24
- Contra-indications for magnetic resonance imaging
- Major depressive disorder (MDD) as defined by the criteria of a DSM-V diagnosis for MDD
- Abuse of alcohol, drugs or benzodiazepines.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Behavioural Therapy (CBT)
Patients who will receive CBT plus clinical monitoring will receive 10 weekly individual sessions (60-75 minutes), tailored to the preferences and needs of each patient.
In each session, a registered psychologist will address specified aspects of (coping with) anxiety and related concerns with a specific focus on behaviour and thoughts associated with anxiety.
|
Cognitive Behavioural Therapy (CBT) is considered the gold standard in psychotherapeutic treatments of anxiety.
CBT is defined as: 'An amalgam of behavioural and cognitive problem-based interventions guided by principles of applied science.
The behavioural interventions aim to decrease maladaptive behaviours and increase adaptive ones by modifying their antecedents and consequences and by behavioural practices that result in new learning.
The cognitive interventions aim to modify maladaptive cognitions, self-statements, or beliefs.' (Arch & Craske, 2009; Craske, 2010).
Patients assigned to clinical monitoring only will receive general education material on coping with PD symptoms and behavioural symptoms such as anxiety.
In addition, they will be followed-up 1 month after baseline assessment via telephone calls to inquire about current anxiety symptoms.
Patients will remain under the care of their personal physicians, who will also monitor their medical and psychiatric status.
|
Other: Clinical monitoring
Patients assigned to clinical monitoring only will receive general education material on coping with PD symptoms and behavioural symptoms such as anxiety.
In addition, they will be followed-up 1 month after baseline assessment via telephone calls to inquire about current anxiety symptoms.
Patients will remain under the care of their personal physicians, who will also monitor their medical and psychiatric status.
Patients who receive clinical monitoring only will be given the option to receive CBT once the trial is completed.
|
Patients assigned to clinical monitoring only will receive general education material on coping with PD symptoms and behavioural symptoms such as anxiety.
In addition, they will be followed-up 1 month after baseline assessment via telephone calls to inquire about current anxiety symptoms.
Patients will remain under the care of their personal physicians, who will also monitor their medical and psychiatric status.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in anxiety score as measured with the Hamilton Anxiety Rating Scale (HARS).
Time Frame: Baseline assessment (T0) and post-treatment assessment (T1; after 10 weeks)
|
Baseline assessment (T0) and post-treatment assessment (T1; after 10 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in cerebral connectivity between limbic and frontal cortices as measured with resting state blood-oxygen-level dependent functional magnetic resonance imaging (BOLD fMRI) and diffusion tensor imaging (DTI)
Time Frame: MRI scanning at baseline (T0) and post-treatment (T1; after 10 weeks)
|
MRI scanning at baseline (T0) and post-treatment (T1; after 10 weeks)
|
Long term clinical effectiveness of the CBT module measured by the change in HARS score
Time Frame: 3 months follow-up (T2) and 6 months follow-up (T3)
|
3 months follow-up (T2) and 6 months follow-up (T3)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Albert FG Leentjens, MD, PhD, Maastricht University Medical Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
January 5, 2016
First Submitted That Met QC Criteria
January 6, 2016
First Posted (Estimate)
January 7, 2016
Study Record Updates
Last Update Posted (Actual)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 17, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11169 (Registry Identifier: DAIDS ES Registry Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Treatment module will be made available for public use.
Study data will be published in peer-reviewed journals.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Neurocrine BiosciencesVoyager TherapeuticsCompletedBrain Diseases | Central Nervous System Diseases | Nervous System Diseases | Parkinson's Disease | Parkinsonian Disorders | Movement Disorders | Neurodegenerative Diseases | Idiopathic Parkinson's Disease | Basal Ganglia DiseaseUnited States
-
Shanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruitingIdiopathic Parkinson's DiseaseChina
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
Kyowa Kirin Co., Ltd.Kyowa Hakko Kirin Pharma, Inc.CompletedIdiopathic Parkinson's DiseaseUnited States, Canada, Czechia, Germany, Israel, Italy, Poland, Serbia
-
Kyowa Kirin Co., Ltd.Kyowa Hakko Kirin Pharma, Inc.CompletedIdiopathic Parkinson's DiseaseUnited States, Canada, Czechia, Germany, Israel, Italy, Poland, Serbia
Clinical Trials on Cognitive Behavioural Therapy (CBT)
-
The University of Hong KongChinese University of Hong Kong; University of OxfordCompletedDepression | InsomniaHong Kong
-
Linkoeping UniversityCompleted
-
University Medicine GreifswaldGerman Federal Ministry of Education and ResearchUnknown
-
University of British ColumbiaHarvard Medical School (HMS and HSDM)Active, not recruitingMild Traumatic Brain Injury | Functional Neurological DisorderCanada
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Orthopaedic Trauma AssociationRecruitingPain, Postoperative | Pain, Acute | Fractures, Closed | Pain, Chronic | Fractures, OpenUnited States, Canada
-
McMaster UniversityCanadian Institutes of Health Research (CIHR)Completed
-
Nova Scotia Health AuthorityCompletedBipolar Disorder | Social PhobiaCanada
-
McMaster UniversityUnity Health Toronto; Hamilton Health Sciences Corporation; Hamilton Academic...TerminatedPain, Postoperative | Fractures, Closed | Fractures, OpenCanada
-
Charite University, Berlin, GermanyGerman Federal Ministry of Education and ResearchCompletedPanic Disorder | Agoraphobia
-
Royal Victoria InfirmaryManchester University NHS Foundation TrustUnknownCough | Idiopathic Pulmonary Fibrosis | BreathlessnessUnited Kingdom